Clinical Trial

PRL2019 in the Treatment of Juvenile Fibromyalgia

Study acronym: IGG-microbiota
Not Yet Recruiting
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Summary
Juvenile Fibromyalgia Syndrome (JFS) is a chronic condition affecting children and adolescents, characterised by widespread musculoskeletal pain and a significant impact on daily life and quality of life. Gastrointestinal symptoms and changes in gut microbiota have been reported in patients with fibromyalgia, suggesting a possible role of the gut-immune system interaction in the disease. This study aims to investigate whether Gabapral®, a food supplement containing the probiotic strain Bifidobacterium adolescentis PRL2019, may help reduce pain symptoms and improve clinical outcomes in paediatric patients with JFS. The hypothesis of this study is that modulation of the gut microbiota with Gabapral® may contribute to improvement of symptoms related to Juvenile Fibromyalgia Syndrome.
Trial Details
NCT Number NCT07738926
Lead Sponsor Istituto Giannina Gaslini
Conditions Fibromyalgia, Fibromyalgia Syndrome
Enrollment 30 participants
Start Date 2026-08-01
Primary Completion 2026-09-01 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-31